A Comparative Study of Olopatadine Hydrochloride Ophthalmic Solution 0.2% QD vs Olopatadine Hydrochloride Ophthalmic Solution 0.1% BID in the Treatment of Allergic Conjunctivitis in Chinese Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 383
- 主要终点
- Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14
研究概览
简要总结
The purpose of this study is to evaluate olopatadine 0.2% QD (once per day) compared to olopatadine 0.1% BID (twice per day) in the treatment of ocular itching associated with allergic conjunctivitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese ethnicity;
- •History of allergic conjunctivitis within the last 2 years;
- •Positive skin prick test or skin intradermal test documented by a lab report within 24 months of, or at the baseline visit;
- •Clinical diagnosis of allergic conjunctivitis with specific signs and symptoms;
- •Understand and sign an informed consent form;
- •Willing and able to make required study visits and follow study instructions, and comply with dosing study medication as instructed;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Contraindications or hypersensitivity to study medications or their components;
- •Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal) in either eye;
- •Any ocular condition that could affect the study outcomes;
- •Presumed or actual ocular infection or history of ocular herpes in either eye;
- •Known history of retinal detachment, diabetic retinopathy, or any progressive retinal disease;
- •Willing and able to avoid the use of any other topical ocular medication(s) (including artificial tear products);
- •Any significant illness that could be expected to interfere with the study, particularly any autoimmune disease;
- •Intraocular surgery in either eye within 6 months, or ocular laser surgery in either eye within 3 months, or anticipation of ocular surgery during the study; ocular trauma in either eye within 3 months of baseline visit;
- •Clinically relevant recent (within 6 months of baseline visit) history of or current severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, autoimmune disease and other relevant systemic diseases that would preclude the safe administration of a topical antihistamine/mast cell stabilizer in the opinion of the Investigator;
- •Use of systemic medication(s) on a chronic dosing regimen for less than 1 month or have changed dosage within the month prior to baseline visit;
- •Use of any disallowed medication (topical, topical ophthalmic, systemic and/or injectable) during the period indicated prior to baseline visit. These medications are also not allowed during the study. Disallowed medications include all anti-allergy therapies including those contained in prescription or over-the-counter sleeping aids;
- •Use of cold compresses on the eyes during the course of the study;
- •Cannot be dosed in both eyes;
- •Cannot avoid contact lens wear during the course of the study;
- •Therapy with another investigational agent within 30 days of baseline visit, or during the study;
- •Women of childbearing potential who are pregnant, intend to become pregnant during the study period, breast-feeding, or not using adequate birth control methods;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
PATADAY
Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% vehicle in the evening, 1 drop in each eye for 14 days
干预措施: Olopatadine Hydrochloride Ophthalmic Solution 0.2% (Drug)
PATADAY
Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% vehicle in the evening, 1 drop in each eye for 14 days
干预措施: Olopatadine 0.2% Vehicle (Drug)
PATANOL
Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
干预措施: Olopatadine Hydrochloride Ophthalmic Solution 0.1% (Drug)
结局指标
主要结局
Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14
时间窗: Baseline, Day 14
Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis.
次要结局
未报告次要终点